transport of medicinal products - event management …€¦ · controllable factors ... –delivery...

Transport of Medicinal

Products

Deirdre O’Brien

Wholesale Distribution Conference

11th November 2014

Transportation Considerations

• Essential function for supplying safe, effective and good quality medicinal product to patients

• Responsibility for the product from receipt →delivery to the customer

• Transportation → extension of your warehouse

• Controls already in place from receipt to dispatch → continue as product leaves the warehouse

• Weak point – potential robbery

211th November 2014

Transportation Planning

Controllable Factors

– Routes

– Delivery time

– Mode of transport

– Packaging

Uncontrollable Factors

– Traffic

– Weather

– Other delays

– Handling

311th November 2014

Chapter 9 - Transportation

Responsibility of the supplying wholesale distributor to:

1. protect medicinal products against

• breakage

• adulteration

• theft

2. maintain temperature conditions during transport

3. demonstrate that medicinal products have not been exposed to conditions that may compromise their quality and integrity

411th November 2014

Overview

1. General Requirements

2. Containers, Packaging & Labelling

3. Cold Chain

4. Security

5. Outsourced Transportation Activities

511th November 2014

1. General Requirements

Transportation (9.2)

• Maintain required storage conditions

• Report deviations to the distributor and customer

• SOP - temperature excursions

• Ensure vehicles and equipment are suitable for use and appropriately equipped to prevent exposure to conditions which could effect quality and integrity of packaging

• SOP - operation and maintenance of all vehicles and equipment

711th November 2014


• Risk assess delivery routes to determine

where temperature controls are required

• Maintain and calibrate temperature

monitoring equipment

• Use dedicated vehicles, where possible

• Non–dedicated vehicles SOP – avoid

product being compromised

811th November 2014


Deliveries

• made to address on delivery note and into

the care or premises of the consignee

• not left on alternative premises

• emergency deliveries outside of normal

business hours - staff should be designated

and SOPs available

911th November 2014

2. Containers, packaging and

labelling

Containers, packaging and labelling (9.3)

Medicinal Products should be transported

in containers that:

• have no adverse effect on quality product

• offer adequate protection from external

influences, including contamination

1111th November 2014


Selection of container and packaging should be based on:

• storage and transportation requirements of the medicinal products

• space required for the amount of medicines

• anticipated external temperature extremes

• estimated maximum time for transportation including transit storage at customs

• qualification status of the packaging

• validation status of the shipping containers



Labelling requirements

• Container labels should:

– include sufficient information on handling and

storage requirements

– include precautions to ensure that products are

properly handled and secured at all times

– enable identification of the contents and its

source


3. Cold Chain

Products requiring special conditions (9.4)

• SOP - delivery process of temperature

sensitive products and seasonal

temperature variations control

• Qualified equipment should be used to

ensure correct transport conditions are

maintained between

manufacture → wholesale distributor → customer


1. Temperature controlled vehicles

• Maintain and calibrate temperature monitoring equipment at regular intervals

• Perform temperature mapping under representative conditions and take into account seasonal variations

• Provide information to customers to demonstrate that products have complied with temperature storage conditions (if requested)


2. Cool packs in insulated boxes

• Locate such that product does not come into direct contact with the cool pack

• Train staff on SOP for assembly of insulated boxes, seasonal configurations and reuse of cool packs

• Implement a system to control the reuse of cool packs to ensure that incompletely cooled packs are not used in error

• Ensure adequate physical segregation between frozen and chilled ice packs


4. Security


Controlled Drugs

• Maintain safe and secure supply chain

• Apply additional controls for delivery

• Implement a protocol for theft



Highly active and radioactive materials

• Transported in safe, dedicated and secure

containers and vehicles

• Relevant safety measures in accordance

with international agreements and national

legislation


5. Outsourced Activities -

Transportation

Outsourced / Contract Transportation (9.2)

• Contract - include requirements of Chapter 7

• Inform transportation providers of the relevant transport conditions applicable to the consignment

• Transport route includes unloading, reloading or transit storage at a transportation hub, pay attention to

• temperature monitoring

• cleanliness

• security of the immediate storage facilities

• Minimise the duration of temporary storage while awaiting the next stage of the transportation route


Chapter 7 - Outsourced Activities (7.1)

1. Correctly defined

2. Agreed by both parties

3. Controlled in order to avoid

misunderstanding which could affect the

integrity of the products

How? Written Contract


Chapter 7 - Outsourced Activities (7.2 & 7.3)

7.2 Responsibilities of the Contract Giver

7.3 Responsibilities of the Contract Acceptor


Responsibilities of the Contract Giver (7.2)

The contract giver remains responsible for the transport activities contracted out, at all times

The contract giver must:

• Assess the competence of the transportation provider

• Ensure the principles and guidelines of GDP are followed

• Perform an audit before commencement and whenever there's a change to the activities

• Define the audit frequency based on risk depending on the nature of the activities

• Provide all information necessary to carry out operations in accordance with specific product requirements and other relevant requirements


Responsibilities of the Contract Acceptor (7.3)

The transportation provider should:

• have adequate

– premises

– equipment

– procedures

– knowledge

– experience

– competent personnel

• refrain from any activity which may adversely affect the quality of products handled

• forward any information that can influence the quality of the product


Responsibilities of the Contract Acceptor (7.3)

The transportation provider should:

• not pass any of the contracted activities to

a third party without approval

• audit the third party

• ensure that wholesale distribution

information is made available in the same

way as between the original contract giver

and acceptor


WHY?

Transportation is an essential function in

supplying safe, effective and good quality

medicinal product to patients

11th November 2014 28

Next Steps

• Review your company’s current

transportation arrangements

• Does your company outsource

transportation?

• Does your company distribute products

requiring special conditions?

• Are the required procedures in place?


Further Information

www.hpra.ie

• Guide to good distribution practice of medicinal products for human use

• Guide to control and monitoring of storage and transportation temperature conditions for medicinal products and active substances

• Guide to import and export licences and letters of no objection for controlled drugs


http://www.hpra.ie/

Thank you for listening

Deirdre O’Brien

[email protected]

01-6764971

mailto:[email protected]

transport of medicinal products - event management …€¦ · controllable factors ... –delivery...

Documents